Urine sampling device and method

ABSTRACT

A one piece, hollow, molded plastic cap is formed with two structural portions and is secured to a container. The first portion is a blunt, bulbous protuberance extending above the major surface of the second portion. The second portion is generally dome-shaped, blending smoothly into the first portion, and has a slit communicating with the container and extending radially from the base of the bulbous protuberance toward the side wall of the cap. The bulbous protuberance is placed in the opening of the vagina in contact with all the surrounding vaginal walls covering and blocking the vaginal introitus while simultaneously positioning the cap so that the urethal meatus is surrounded by the slit. The base of the container is lifted vertically slightly thereby sealingly contacting the surrounding tissue with dome-shaped portion. Means are also provided to vent the container during the taking of the urine sample. The base of the container is fitted with a standard closure for substitution with the urine sampling cap to seal the container.

[ Aug. 19, 1975 URINE SAMPLING DEVICE AND METHOD [76] Inventor: BarbaraAnn Logiadis, 1 l6 Pinehurst Ave., Apt. J-24, New York, NY. 10033 [22]Filed: Aug. 23, I973 211 Appl. No.: 390,895

[52] US. Cl. 128/2 F; 4/110; 128/295 [51] Int. Cl A6Ib 10/00 [58] Fieldof Search 128/2 F, 295; 4/110 [56] References Cited UNITED STATESPATENTS 622,631 4/1899 Orbeton 4/110 940,756 11/1909 Van Vechten 4/1 103,033,222 5/1962 Connolly 4/110 X 3,335,714 8/1967 Giesy 128/2 F3,459,174 8/1969 Walker.. 128/2 F 3,485,233 12/1969 Cord 128/2 F3,518,164 6/1970 Andelin et al 128/2 F X 3,528,423 9/1970 Lee 128/2953,556,102 1/1971 Davis v 128/295 3,583,388 6/1971 Hovick 128/2 F FOREIGNPATENTS OR APPLICATIONS 996,370 6/1965 United Kingdom 4/1 1() PrimaryE.\'aminerKyle L. Howell Attorney, Agent, or Firm-Kenyon 8L KenyonReilly Carr & Chapin [57] ABSTRACT A one piece, hollow, molded plasticcap is formed with two structural portions and is secured to acontainer. The first portion is a blunt, bulbous protuberance extendingabove the major surface of the second portion. The second portion isgenerally dome-shaped, blending smoothly into the first portion, and hasa slit communicating with the container and extending radi ally from thebase of the bulbous protuberance toward the side wall of the cap. Thebulbous protuberance is placed in the opening of the vagina in contactwith all the surrounding vaginal walls covering and blocking the vaginalintroitus while simultaneously positioning the cap so that the urethalmeatus is surrounded by the slit. The base of the container is liftedvertically slightly thereby sealingly contacting the surrounding tissuewith dome-shaped portion. Means are also provided to vent the containerduring the taking of the urine sample. The base of the container isfitted with a standard closure for substitution with the urine samplingcap to seal the container.

14 Claims, 4 Drawing Figures 'URINE SAMPLING DEVICE AND METHODBACKGROUND OF THE INVENTION 1. Field of the Invention The inventionrelates to a portable device for taking urine samples of the type whichis utilized by being momentarily pressed against the female genitaliawhile the urine sample is being taken and to an improved process oftaking urine samples. More specifically the invention relates to animproved molded plastic cap of a unique shape mounted to a container andits manner of use so that the cap is easily positioned with respect tothe urethral meatus and the urine sample is simply and readily taken.

2. Description of the Prior Art A variety of female intravaginal urinalsare known which are designed to be worn by the female for long periodsof time and are particularly suited for bedfast, incontinent orincapacitated persons. These devices usually have a member which isinserted into the vagina and presses against the anterior vaginal wall.Such devices are strapped to the female and attempt to prevent leakageor seepage in all positions, sitting, lying or standing. Some suchdevices surround the entire genital area forward of the vagina. None ofthe aforesaid devices are adapted for momentary use for taking urinesamples, as is applicants device, but are more or less permanent bodyfixtures. One such prior art device is inserted into the vaginal cavityand is held in place by an absorbent pad strapped to the wearer. Anotherprior art device uses a suction head attached to a vacuum source, thesuction head shaped as a modified cast of the entire female genitaliawith ducts leading to the suction line. None provide a one piece moldedplastic cap for a urine sampling device having applicants uniquestructure.

The problem of providing a simple, disposable device usable for taking aurine sample without the annoying and unpleasant prospect of urinatingon ones hands and clothing and on the device itself and with the hope ofproviding a urine specimen free of extraurethral contamination therebyreflecting the condition of the urine in the bladder was tackled byother numerous persons in the past besides applicant. One prior artdevice includes a foldable thermoplastic coated paper blank whichunfolds into a funnel. Similarly, another device includes a molded orfoldable plastic form with an exit hole that can be capped off. Bothdevices are widemouthed type devices covering the entire genital areaand are discarded after use by flushing or otherwise. Neither is a capfor a container as is applicants device and neither discloses applicantsunique structure. Another apparatus is designed to surround the urethralmeatus with a compressible resilient pad which has a central opening andis connected to a tube and container. The pad is positioned by movingthe flask so that a surface portion of the pad presses against thedistal end of the anterior vaginal wall and through prolapse of themeatus and surrounding tissue a protrusion is formed which extends intothe central opening. A separate vent pipe is also provided because thepad compresses and distorts sealing the central opening and preventingair from escaping as the sample is taken. This device, although similarto applicants device, does not disclose a one piece molded plastic capfor a container having applicants unique structure for providing asimple device for taking urine samples. Also, the last mentioned devicedoes not position the apparatus by placing in the vaginal opening ablunt, bulbous protuberance which contacts all the surrounding vaginalwalls to position a slit around the urethral meatus.

SUMMARY OF THE INVENTION The invention is in a specially configured capfor a container and its method of use in taking female urine samples.The cap has two portions, a generally domelike shaped portionconstituting the major surface portion of the cap and a bulbousprotuberance portion extending therefrom. The dome-shaped portion isprovided with a radial slit extending from the base of the bulbousportion almost to the side wall of the dome portion. The slitcommunicates with the container which is secured through coupling meansto the base of the cap. The container also carries a standard closuresecured to the base of the container. The bulbous portion is placed inthe vaginal opening in snug contact with the surrounding vaginal wallsspreading the labia majora and minora while positioning the slit aroundthe urethral opening. Pressing the dome-like portion against the bodyholds back the labia and seals the area surrounding the slit. The angleat which the container is pressed against the body is adjusted so that asmall portion of the slit near the side wall of the dome remains open tothe atmosphere and acts as a vent as the urine sample is taken.Alternatively, a separate vent hole is located in the side wall adjacentthe slit.

It is an object of this invention to provide a one piece molded plasticcap which provides a simple effective external device for taking femaleurine samples without the risk of urinating on ones hands or clothes oron the device itself and without the risk of extraurethralcontamination.

It is a further object to provide a container for use in combinationwith the cap and a standard closure carried by the container to providea small, complete, inexpensive urine sample-taking package.

It is an object to provide an improved process for the taking of femaleurine samples.

It is a further object to provide a disposable device for taking urinesamples which can be kept sterile in sealed sterile bags until ready foruse, and which, if desired, can be recycled and sterilized for reuse.

It is an object to provide a urine sampling device which provides ameans for venting the device during taking of the sample. I

Additional objects will be evident from the description of the drawingsand preferred embodiments described below.

DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded elevation view showingthe cap, the container and the standard closure.

FIG. 2 is a sectional side view showing the cap, the container and thestandard closure ready for use.

FIG. 3 is a partial sectional view showing the invention in positionduring use.

FIG. 4 is a sectional side view showing the standard closure secured tothe top of the container.

DESCRIPTION OF THE PREFERRED EMBODIMENT;

. smoothly into the portion 20 which blends smoothly into portion 30.The dome portion 20 is formed with slit 22 therethrough which is incommunication with a container secured to the base of the cap anddescribed below The slit 22 extends radially of the cap from adjacentthe base of the portion 30 nearly to the side wall 21. The slit 22 iscentrally located in portion 20.

t The portion 30 is a smooth, blunt, bulbous protuberance extendinga.short distance above the major surface portion 20 and generally alonga line parallel to the longitudinal axis of the portion 20. The portion30 is preferably round but also may be elliptical with the longdimension aligned with the slit. The protuberance 30 at its widestdiameter is about 1 /2 inches and extends approximately three-quartersinch beyond the dome portion 20.

' Thebase of the cap 21 is provided with means 23 for coupling the capto a container 40. Preferably this is accomplished by internal screwthreads 23 which cooperate with'external threads on the top of thecontainer.

An internal annular bead 24 instead of threads could alsobe used to snapthe cap over a cooperating lip on the container.

The container 40 is conventional and can be either glass or plastic orthe like.

One additional optional feature of the container is the provision of astandard screw-n or snap-on closure 50 conveniently carried'at the base51 of the container so that after the urine sampleis taken, the slittedfemale urine sampling cap is removed and replaced by the standardclosure 50 to seal the container from the atmosphere providing acomplete urine sampling package which can be conveniently left at adoctors office or lab or the like.

. The coupling means at the base of the slitted cap and the couplingmeans at the base of the container are compatible, i.e., both screwthreads or snap-on, so that the urine cap and closure 50 can beinterchanged.

The bulbous protuberance 30 is not intended as an internal structure.Rather, the primary purpose of the bulbous protuberance 30 is as apositioning device for locating the slit 22 around the urethral meatus60 and is best shown in FIG. 3. The positioning is accomplished by firstplacing the bulbous protuberance 30 in the opening of the vagina tocover and block the vaginal introitus and to spread the labia majora andminora thereby exposing the urethral meatus. Thus once placed inposition, the protuberance 30 snugly contacts all of the surroundingvaginal walls and automatically positions the slit, once the slit isvertically aligned with the persons body, to surround the urethralmeatus. The next movement is simply to raise the lower end of thecontainer slightly and press the dome-like portion against the bodytissue between the labia majora and minora permitting the slit tosurround the urethral meatus. A slight pressing action at this pointwill not only hold back the labia majora and minora so that there is nointerference with taking the sample, but also prevents inadvertentmovement of the slit out of its position surrounding the urethralopening. Additionally, the pressing seals the contact between the tissueand the cap so that no leakage occurs in taking the urine samples whichis the final step. The urine passes directly from the urethral meatusinto the container and is not contaminated by any extraurethralbacteria. Thus, an external device is provided for taking a sterileurine sample.

Since in most cases the container is not completely filled with urineduring the taking of a sample, a vent is not necessary.However,'applicants device inherently provides for a vent should thevent be desired. It is noted that it is not necessary that the entirearea of contact around the slit be sealed. The length of the slit ispreferably 1 inch to 1% inch, and since the portion 20 is dome-like andcontoured, there is a small portion 25 of the slit next to the side wall21 which may remain open to the atmosphere for venting air from thecontainer while the urine sample is being taken. This is accomplished byadjusting the angle at which the container is pressed against the body.See FIG. 3. It is only necessary to lower the bottom end of thecontainer slightly to expose the uppermost portion 25 of the slit toatmosphere. An alternative means of venting is to provide a small hole26 in the side wall 21 adjacent the end of the slit 22.

The aforesaid process can be accomplished with one hand, freeing theother hand to keep clothing from interfering with the process.

Following the taking of the urine sample, the slitted cap 10 is removed,the closure cap 50 is removed from the base of the container and issecured to the top of the container to seal it from the atmosphere.

Preferably the entire package including the slitted cap 10, thecontainer 40 and the standard closure 50 is shipped in a single sterilesealed wrapping in which it is retained until it is used. Optionally thethree elements can be separately sealed and shipped, being assembled atthe time of use. In this manner a completely sterile package is providedfor obtaining a completely uncontaminated urine sample. Following use,the entire package is preferably disposed of since it is relativelyinexpensive. However, if desired, it can be sterilized again and reused,particularly if glass containers are used. I

I claim:

1. A one-piece cap of smooth, impermeable, heat sterilizable materialfor use with a collection container for taking a human female urinespecimen comprising: a dome-like major surface in the form of an oblatehemispheroid terminating in a cylindrical skirt sized to fit the top ofa specimen container;

an eccentric generally hemispherical protrusion having a diameter abouthalf the skirt diameter and located to one side of and extending abovethe apex of the major surface;

an intermediate surface smoothly blending the base of the protrusioninto the major surface; and

an elongated slot through the major surface communicating with theinterior of the cap and extending from about the center of the majorsurface radially away from the eccentric protrusion, the protrusionbeing adapted to occlude the vaginal opening of a female person whenpressed thereagainst to pre vent vaginal secretions from contaminatingthe specimen, the width of the slot being adapted to encompass theurethral meatus, and the length of the slot being at least equal to theperineal distance from the vaginal opening to the urethral meatus forthe normal range of human female anatomy.

2. The cap of claim 1 wherein the slot is of a length adapted to extendbeyond the maximum normal perineal spacing between vaginal opening andurethral me atus of the normal human female into the region of increaing curvature of the oblate major surface near the skirt to provide avent from the interior of the container when the flattened portion ofthe oblate spheroid is pressed into sealing contact with the perinealtissue adjacent to the slot when taking a specimen.

3. The cap of claim 1 further comprising a vent hole in the skirtadjacent to the end of the slot for venting the container.

4. The cap of claim 1 wherein the diameter of the protrusion is about 1/2 inches at its widest dimension and the protrusion extends about threequarters of an inch beyond the apex of the major surface.

5. The cap of claim 1 wherein the slot is about onequarter inch wide and1% inch long.

6. The cap of claim 1 composed of a plastic material capable ofretaining its shape at temperatures high enough to insure sterilization.

7. The cap of claim 6 further comprising an annular bead on the insideof the skirt sized to snap over a corresponding lip on a container.

8. The cap of claim 1 further comprising internal threads formed in thecylindrical skirt for mating engagement with a threaded container.

9. The cap of claim 1 in combination with an openmouth container forcollecting a urine specimen through the slot in the cap, the combinationcomprising mounting means on the inside of the cap skirt and cooperativemounting means on the outside of the container mouth for removablyfixing the cap on the container.

10. The combination of claim 9 further comprising:

a base on the container having the same diameter as the container mouth,

external mounting means on the side of the base identical to thecooperative mounting means on the outside of the container mouth, and

a sealing closure for the container removably mounted on the base withthe interior of the closure facing the base, the combination of thecontainer, collector cap and closure being sterilized so that when aurine sample has been taken, the closure can be removed from the basemounting means and substituted for the slotted collector cap with thesterile interior of the closure exposed to the interior of the containerfor sealing the container and protecting its contents againstcontamination.

11. The method of obtaining a self-collected uncontaminated urinespecimen from a human female by means of a sterile container equippedwith a removable one-piece sterile domed cap having a generally oblatehemispheroidal major surface, an eccentric generally hemisphericalprotrusion approximately half the diameter of the cap located to oneside of and extending I above the apex of the major surface, and anelongated slot through the major surface extending from near the apexradially away from the eccentric protrusion comprising the steps of:

holding the container in one hand with the slot in the cap facingforwardly from the eccentric protrusion; placing the eccentricprotrusion against the vaginal opening to spread the inner and outerlabia and to block the vaginal opening for preventing vaginal secretionsfrom entering the container through the slot; raising the lower end ofthe container slightly to press the region of the major surfacesurrounding the slot into sealing contact with the perineal tissue withthe slot enclosing the urethral meatus; and passing a specimen of urinefrom the urethral meatus through the slot in the container. 12. Themethod of claim 11 further comprising the step of venting the containerwhile passing the urine specimen through the slot into the container.

13'. The method of claim 12 wherein the elongated slot in the cap of thecontainer extends beyond the flattened region of the major surface, andthe step of venting the container comprises leaving the outer portion ofthe slot open to the atmosphere while passing the urine specimen intothe container.

14. The method of claim 11 wherein the container is further equippedwith a sterile closure cap removably mounted on the base of thecontainer, and further comprising the steps of:

removing the slotted cap from the top of the container after collectingthe urine specimen, removing the closure cap from the base of thecontainer, and

securing the closure cap to the top of the container so that the sterilesurface of the closure cap that previously faced the base of thecontainer is exposed to the interior of the container for sealing thecontainer and preventing contamination of the specimen.

1. A one-piece cap of smooth, impermeable, heat sterilizable materialfor use with a collection container for taking a human female urinespecimen comprising: a dome-like major surface in the form of an oblatehemispheroid terminating in a cylindrical skirt sized to fit the top ofa specimen container; an eccentric generally hemispherical protrusionhaving a diameter about half the skirt diameter and located to one sideof and extending above the apex of the major surface; an intermediatesurface smoothly blending the base of the protrusion into the majorsurface; and an elongated slot through the major surface communicatingwith the interior of the cap and extending from about the center of themajor surface radially away from the eccentric protrusion, theprotrusion being adapted to occlude the vaginal opening of a femaleperson when pressed thereagainst to prevent vaginal secretions fromcontaminating the specimen, the width of the slot being adapted toencompass the urethral meatus, and the length of the slot being at leastequal to the perineal distance from the vaginal opening to the urethralmeatus for the normal range of human female anatomy.
 2. The cap of claim1 wherein the slot is of a length adapted to extend beyond the maximumnormal perineal spacing between vaginal opening and urethral meatus ofthe normal human female into the region of increasing curvature of theoblate major surface near the skirt to provide a vent from the interiorof the container when the flattened portion of the oblate spheroid ispressed into sealing contact with the perineal tissue adjacent to theslot when taking a specimen.
 3. The cap of claim 1 further comprising avent hole in the skirt adjacent to the end of the slot for venting thecontainer.
 4. The cap of claim 1 Wherein the diameter of the protrusionis about 1 1/2 inches at its widest dimension and the protrusion extendsabout three-quarters of an inch beyond the apex of the major surface. 5.The cap of claim 1 wherein the slot is about one-quarter inch wide and 11/4 inch long.
 6. The cap of claim 1 composed of a plastic materialcapable of retaining its shape at temperatures high enough to insuresterilization.
 7. The cap of claim 6 further comprising an annular beadon the inside of the skirt sized to snap over a corresponding lip on acontainer.
 8. The cap of claim 1 further comprising internal threadsformed in the cylindrical skirt for mating engagement with a threadedcontainer.
 9. The cap of claim 1 in combination with an open-mouthcontainer for collecting a urine specimen through the slot in the cap,the combination comprising mounting means on the inside of the cap skirtand cooperative mounting means on the outside of the container mouth forremovably fixing the cap on the container.
 10. The combination of claim9 further comprising: a base on the container having the same diameteras the container mouth, external mounting means on the side of the baseidentical to the cooperative mounting means on the outside of thecontainer mouth, and a sealing closure for the container removablymounted on the base with the interior of the closure facing the base,the combination of the container, collector cap and closure beingsterilized so that when a urine sample has been taken, the closure canbe removed from the base mounting means and substituted for the slottedcollector cap with the sterile interior of the closure exposed to theinterior of the container for sealing the container and protecting itscontents against contamination.
 11. The method of obtaining aself-collected uncontaminated urine specimen from a human female bymeans of a sterile container equipped with a removable one-piece steriledomed cap having a generally oblate hemispheroidal major surface, aneccentric generally hemispherical protrusion approximately half thediameter of the cap located to one side of and extending above the apexof the major surface, and an elongated slot through the major surfaceextending from near the apex radially away from the eccentric protrusioncomprising the steps of: holding the container in one hand with the slotin the cap facing forwardly from the eccentric protrusion; placing theeccentric protrusion against the vaginal opening to spread the inner andouter labia and to block the vaginal opening for preventing vaginalsecretions from entering the container through the slot; raising thelower end of the container slightly to press the region of the majorsurface surrounding the slot into sealing contact with the perinealtissue with the slot enclosing the urethral meatus; and passing aspecimen of urine from the urethral meatus through the slot in thecontainer.
 12. The method of claim 11 further comprising the step ofventing the container while passing the urine specimen through the slotinto the container.
 13. The method of claim 12 wherein the elongatedslot in the cap of the container extends beyond the flattened region ofthe major surface, and the step of venting the container comprisesleaving the outer portion of the slot open to the atmosphere whilepassing the urine specimen into the container.
 14. The method of claim11 wherein the container is further equipped with a sterile closure capremovably mounted on the base of the container, and further comprisingthe steps of: removing the slotted cap from the top of the containerafter collecting the urine specimen, removing the closure cap from thebase of the container, and securing the closure cap to the top of thecontainer so that the sterile surface of the closure cap that previouslyfaced the base of the container is exposed to the interior of thecontainer for sealing the container and preventing contamination of thespecimen.